GenomeDx BioSciences Release: Validation Study of Decipher Genomic Prostate Cancer Test to be Published in Journal of Urology: Decipher Correctly Reclassifies 60 Percent of "High Risk" Patients as "Low Risk" and Identifies Patients Four Times More Likely to Develop Metastatic Prostate Cancer

SAN DIEGO, June 25, 2013 /PRNewswire/ -- GenomeDx Biosciences today announced the publication of data demonstrating its Decipher test outperformed existing risk assessment tools for predicting metastatic prostate cancer in patients following prostate surgery. Decipher more accurately classified prostate cancer patients at risk of developing metastasis compared to conventional clinical variables such as Gleason score and PSA. In the study, Decipher was able to pinpoint a high risk patient group that was four times more likely to have metastatic cancer. Conversely, Decipher reclassified 60 percent of clinically high risk patients as low risk, who were 2.5 times less likely to have metastatic cancer. The accurate classification of patient risk of metastasis is an important advancement toward the identification of patients that should be treated aggressively and those that should not.

Decipher measures 22 genomic biomarkers associated with metastatic cancer to generate a result that indicates the likelihood of metastasis. The result is completely independent of PSA and other existing clinical variables, providing truly new, unbiased and actionable information that physicians and patients can use to make post-operative treatment plans. The study, titled "Validation of a Genomic Classifier that Predicts Metastasis Following Radical Prostatectomy in an At Risk Patient Population," is in press and available online in the Journal of Urology. Patients can contact their physician now to see if they would benefit from the Decipher test through ongoing clinical studies. GenomeDx expects to make Decipher more widely available to U.S. patients in the third quarter of this year.

"Currently men with advanced or high risk prostate cancer have heterogenous outcomes, and this test can help better risk-stratify these men after surgery," said R. Jeffrey Karnes, MD, a urologist at Mayo Clinic and principal author on the paper. "In this study, we found the test was able to re-classify from high-risk to low-risk 60 percent of patients, including high Gleason score patients that, upon clinical follow-up, had exceptionally good outcomes and never needed secondary therapy."

"This study was conducted in a population of 1,010 men at elevated risk of recurrence following prostate surgery and found that the overall incidence of metastatic disease was only 6 percent after five years. Current guidelines from the National Comprehensive Cancer Network and the American Urological Association recommend that men in this population receive therapies that can have significant side effects even though few of the men will derive any benefit," said Doug Dolginow, MD, CEO of GenomeDx. "Clearly there is a need for a test like Decipher that can flag truly aggressive tumors with inherently greater potential for metastasis and distinguish them from patients' tumors that will essentially be cured by surgery."

The results of the study demonstrate that Decipher could independently forecast which patients developed metastasis and showed better performance over any clinical variable or prediction model for metastasis, all of which carry limitations that can confound treatment decisions. In the study, 60 percent of patients that had a low Decipher result also had a five-year cumulative incidence of metastasis of just 2.4 percent. In contrast, 20 percent of patients with a high Decipher result had a 22.5 percent incidence of metastasis after five years. Interestingly, data suggest that Decipher may identify a subset of men with adverse pathology features that never develop clinical metastasis.

"The study is based on a large patient cohort with long-term follow-up, and Decipher is forecasting an important clinical endpoint: metastasis-free survival," explains Peter Black, MD, a urologist at the University of British Columbia and author on the paper. "Each year, tens of thousands of post-prostatectomy patients and their physicians are using limited information to tackle agonizing decisions about the use and timing of secondary therapies such as radiation. Decipher is shown to be especially helpful in telling us which patients likely need no further therapy because they have a lower risk of progression. It makes me confident that this will be the test that raises the bar on the kind of information required to make a post-RP decision."

In the prospectively-designed study, 1,010 patients treated with radical prostatectomy between 2000 and 2006 were identified from the Mayo Clinic tumor registry for a case-cohort study design. Genome-wide expression profiles were generated on a random sample of an at-risk population (219 patients, including 69 patients that eventually developed metastasis on study follow-up). Decipher results were generated from the genome-wide profiles from these patients in a blinded fashion.

Decipher is a transformative prognostic test that provides a direct measure of the true biological risk of potentially lethal metastatic prostate cancer independently of PSA level and other risk factors. Decipher measures and analyzes the activity levels of multiple markers associated with aggressive prostate cancer to generate a patient's tumor-specific risk of disease progression after surgery (radical prostatectomy). When used in conjunction with conventional risk assessment tools, validation data indicates that Decipher more accurately stratified a patient's risk for developing metastatic cancer following radical prostatectomy.

Mayo Clinic has a financial interest in technology licensed to GenomeDx.

About GenomeDx Biosciences

GenomeDx Biosciences develops and commercializes genomic tests for prostate and other urologic cancers that impact treatment decision-making, improve patient outcomes and ultimately reduce healthcare costs. The company's first test, Decipher, is a transformative prognostic test that provides a direct measure of the true biological risk of metastatic prostate cancer independent of PSA and other risk factors. GenomeDx is based in San Diego, California and Vancouver, British Columbia. More information is available at www.genomedx.com.